Unique Device Identification (UDI)
2013-09-24
- U.S. Food and Drug Administration (FDA)
The Unique Device Identification (UDI) system is a global standard for marking and identifying medical devices throughout their lifecycle. Mandated by regulators like the US FDA, a UDI consists of a device identifier (DI) for the specific model and a production identifier (PI) for batch, serial number, or expiration date. It enhances traceability, post-market surveillance, and patient safety.
The Unique Device Identification (UDI) system was established to create a single, standardized method for identifying medical devices. Before UDI, tracking devices was difficult due to proprietary and non-standard numbering systems, which complicated recalls and adverse event analysis. The UDI code, which must appear in both human-readable and machine-readable (e.g., barcode, RFID) formats on the device label and packaging, is composed of two parts.
The first is the Device Identifier (DI), a mandatory, fixed portion that identifies the specific version or model of a device and the labeler (manufacturer). The second is the Production Identifier (PI), a conditional, variable portion that contains information like the lot or batch number, serial number, expiration date, and manufacturing date. This two-part structure allows for precise tracking not just of a device model, but of a specific production run or even an individual unit.
Manufacturers are required to submit their UDI information to a publicly accessible database, such as the FDA’s Global Unique Device Identification Database (GUDID). This database serves as a reference catalog for every device, linking the UDI to key product attributes. The implementation of UDI is a significant step towards a more transparent and secure global healthcare supply chain, enabling stakeholders—from manufacturers and distributors to hospitals and patients—to reliably identify a device and access its critical information.
UNESCO Nomenclature: 3308
– Industrial engineering
Precursors
- development of barcode and rfid technology
- universal product code (upc) system in retail
- need for improved post-market surveillance following major device recalls
- globalization of the medical device supply chain
- creation of public health databases
Applications
- rapid and precise medical device recalls
- improved adverse event reporting
- anti-counterfeiting measures in the medical supply chain
- better management of hospital inventory
- integration into electronic health records for device tracking per patient
Potential Innovations Ideas
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Related to: UDI, unique device identification, medical device tracking, FDA, gudid, supply chain management, patient safety, traceability, device identifier, production identifier.